510(k) · Cleared
ClearedInnofluor Gentamicin Assay System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxis Intl., Inc. · LGQ Fluorescence Polarization Immunoassay, Phenobarbital
Cleared on Aug 1, 1997 after a 39-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 1, 1997
- Review
- 39 days
- Class
- Class II
- Product code
- LGQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | INNOFLUOR® Gentamicin Assay System, Existing Named without a submission number | |
| * | — | Abbott Gentamicin Assay Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LGQ devicesLGQ Fluorescence Polarization Immunoassay, Phenobarbital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGQ
FDA has decided no LGQ device since 2007.
Median 510(k) review, days · LGQ
Too few LGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LGQ
No recall names LGQ since 2007.
Adverse event reports per year · LGQ
2in 2013
MAUDE reports naming product code LGQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set are packaged and sold separately, but are referred to collectively, in all associated product labeling, as the INNOFLUOR® Gentamicin Assay System. The INNOFLUOR® Gentamicin Assay System is an in vitro diagnostic device intended for the quantitative determination of total Gentamicin in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay…
Read the full statement (190 words)
The INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set are packaged and sold separately, but are referred to collectively, in all associated product labeling, as the INNOFLUOR® Gentamicin Assay System.
The INNOFLUOR® Gentamicin Assay System is an in vitro diagnostic device intended for the quantitative determination of total Gentamicin in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.
The INNOFLUOR® Gentamicin Reagent Set is intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Gentamicin Assay System.
The INNOFLUOR® Gentamicin Calibrator Set is intended for use in the calibration of the INNOFLUOR® Gentamicin Assay System.
The INNOFLUOR® Gentamicin Reagent Set and Calibrator Set are used together to generate the calibration curve on the TDx®/TDxFLx® analyzer. The calibration curve must be established prior to assaying unknown samples. Prior to performing the calibration procedure, the correct analyzer operating parameters must be set by following the instructions provided in the Product Insert Supplement, which is included with every INNOFLUOR® Gentamicin Reagent Set.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972331 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972331: Innofluor Gentamicin Assay System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972331
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026